FDA Anticipates Slow, Rocky Start for Biosimilars Program: Woodcock

The FDA is projecting a sluggish start for its new biosimilars approval pathway. The agency expects that limited early funding, delays while it develops guidance and legal challenges will slow initial approvals. “This will be an under-resourced program for the next few years,” CDER Director Janet Woodcock warned attendees of the Drug Information Association/FDA Biosimilar Conference Wednesday.
Drug Industry Daily